NEW EUROPEAN COMMISSION REGULATION ON VARIATIONS TO THE TERMS OF MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS AND ITS IMPACT ON CROATIAN LEGISLATION

被引：0

作者：

Martinac, Adrijana Ilic ^{[1
]}

Tomic, Sinisa ^{[1
]}

Simicic, Mirna ^{[2
]}

机构：

[1] Agcy Med Prod & Med Devices, Zagreb 10000, Croatia

[2] Jadran Galenski Lab DD, Rijeka, Croatia

来源：

ARHIV ZA HIGIJENU RADA I TOKSIKOLOGIJU-ARCHIVES OF INDUSTRIAL HYGIENE AND TOXICOLOGY | 2010年 / 61卷 / 03期

关键词：

efficacy; Medicinal Products Act; quality; registration documentation; safety;

D O I：

10.2478/10004-1254-61-2010-2015

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

引用

页码：311 / 322

页数：12

共 30 条

[21] NEW PROPOSED EUROPEAN COMMISSION PHARMACEUTICAL REGULATION - POTENTIAL CHANGES AND IMPACT ON MANUFACTURERS WITH A FOCUS ON EASTERN & SOUTHERN EUROPEAN MEMBER STATES
Yap, B.
Sood, M.
Tomassy, J.
Tamayo, M., I
[J]. VALUE IN HEALTH, 2023, 26 (12) : S272 - S272
[22] KN Challenges associated with antimicrobial resistance for scientists and regulators considering new European Action Plan and future legislation on veterinary medicinal products
Pokludova, L.
[J]. JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS, 2018, 41 : 32 - 32
[23] ORPHAN DRUGS - HOW WILL THE NEW PROPOSED EUROPEAN UNION (EU) COMMISSION PHARMACEUTICAL REGULATION IMPACT THERAPIES FOR RARE DISEASES?
Yap, B.
Tomassy, J.
Hinds, C. S.
[J]. VALUE IN HEALTH, 2023, 26 (12) : S287 - S287
[24] 10-year report on the European Paediatric Regulation and its impact on new drugs for children's cancers
Pearson, Andrew D. J.
Heenen, Delphine
Kearns, Pamela R.
Goeres, Anne
Marshall, Lynley V.
Blanc, Patricia
Vassal, Gilles
[J]. LANCET ONCOLOGY, 2018, 19 (03): : 285 - 287
[25] “Novartis Pharma”Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying Down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency – Novartis Pharma GmbH v. Apozyt GmbH
[J]. IIC - International Review of Intellectual Property and Competition Law, 2014, 45 (2) : 227 - 227
[26] The new European Union Flavouring Regulation and its impact on essential oils: production of natural flavouring ingredients and maximum levels of restricted substances
Demyttenaere, Jan C. R.
[J]. FLAVOUR AND FRAGRANCE JOURNAL, 2012, 27 (01) : 3 - 12
[27] Safety reporting in clinical trials: new regulatory requirements arising by the regulation (EU) No 536/2014 of the European parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use
Duranton, S.
Autexier, M. D.
Carlhant-Kowalski, D.
Chiffoleau, A.
Jamet, A.
Jobert, A.
Morvan, F.
Mouchel, C.
[J]. FUNDAMENTAL & CLINICAL PHARMACOLOGY, 2016, 30 : 71 - 71
[28] ‘‘AstraZeneca’’EC Treaty, Art. 82; Council Directive 65/65/EEC of 26 January 1965 on the Approximation of Provisions Laid Down by Law, Regulation or Administrative Action Relating to Medicinal Products, Art. 4 – AstraZeneca AB and AstraZeneca plc v. European Commission and European Federation of Pharmaceutical Industries and Associations (EFPIA)
[J]. IIC - International Review of Intellectual Property and Competition Law, 2014, 45 (1) : 117 - 119
[29] Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the change of terms of the authorisation of "Avatec 15%" as a feed additive, regarding a new formulation (Avatec((R)) 150G) in accordance with Regulation (EC) No 1831/2003 (Question No EFSA-Q-2004-172) Adopted on 8 August 2005
Anadon, Arturo
Arzo, Margarita Arboix
Bories, Georges
Brantom, Paul
de Barbera, Joaquim Brufau
Chesson, Andrew
Cocconcelli, Pier Sandro
de Knecht, Joop
Dierick, Noel
Flachowsky, Gerhard
Franklin, Anders
Gropp, Jurgen
Haldorsen, Anne-Katrine Lundebye
Halle, Ingrid
Mantovani, Alberto
Peltonen, Kimmo
Rychen, Guido
Sanders, Pascal
Soares, Amadeu
Wester, Pieter
Windisch, Wilhelm
[J]. EFSA JOURNAL, 2005, 3 (08):
[30] Grundzüge des neuen Genehmigungsverfahrens für klinische Arzneimittelprüfungen im Rahmen der Verordnung (EU) Nr. 536/2014 und der Zusammenarbeit zwischen den MitgliedstaatenMain characteristics of the new authorisation procedure for clinical trials with medicinal products according to regulation (EU) no 536/2014 and the cooperation between the member states
Thomas Sudhop
Claudia Riedel
Hartmut Krafft
[J]. Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, 2023, 66 : 3 - 11

← 1 2 3 →